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Disprol Paediatric

Package Leaflet Information for the User

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet, you may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    Contains paracetamol. Follow the dosage instructions carefully.

-    Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.

If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Disprol Paediatric is and what it is used for

2.    Before you take Disprol Paediatric

3.    How to take Disprol Paediatric

4.    Possible side effects

5.    How to store

6.    Further information

1.    What Disprol Paediatric is and what it is used for

The ingredient which makes this medicine work is paracetamol, which is effective in relieving pain (analgesic) and reducing fever by lowering the body temperature (antipyretic).

Disprol Paediatric is used to relieve headaches, migraine, teething pain, toothache, sore throat, period pain, nerve pain, aches and pains and fever (caused by colds and flu, vaccinations or immunisations).

2.    Before you take Disprol Paediatric Do not give this medicine to

•    a child or anyone who is allergic to paracetamol or any of the other ingredients (see Section 2 ‘Important information about some of the ingredients’and Section 6 ‘Further information’).

Take special care and ask a pharmacist or doctor before giving this medicine

•    to a child or anyone with severe kidney or liver problems. (The risk of an overdose is greater in people with non cirrhotic liver disease.)

•    to a child who suffers from diabetes.

Taking other medicines

•    Do not use with any other paracetamol containing products.

•    Ask a pharmacist or doctor before giving this medicine to a child or anyone who is taking or has recently taken any other medicines including non prescription medicines especially:

-    metoclopramide (to prevent nausea and vomiting)

-    cholestyramine (for high cholesterol)

-    anticoagulants (to thin the blood) such as warfarin

-    barbiturates or tricylic antidepressants.

Taking this medicine with food and drink

Alcohol may increase the likelihood of side effects of paracetamol. To be noted by older patients who take this medicine.

Pregnancy and breast-feeding

Ask a doctor or pharmacist before taking this or any medicine if you are pregnant or breastfeeding.

Important information about some of the ingredients

•    If you have been told by a doctor that your child has an intolerance to fructose, check with your doctor before taking this medicine (as it contains hydrogenated glucose syrup).

•    Contains glycerol (which can be harmful in high doses and can cause headache, stomach upsets and diarrhoea).

•    Contains benzoates (which can rarely cause allergic reactions such as skin rashes).

3. How to take Disprol Paediatric

For oral use only. Disprol Paediatric has a banana flavour and is easy to swallow. Check the cap seal is unbroken before first use. Never give more medicine than shown in the tables. Always use the spoon supplied with the pack. It is important to shake the bottle for at least 10 seconds before use.

Age	Dose
For post-vaccination fever for babies aged between 2 - 3 months	One 2.5 mL spoonful If necessary, after 4-6 hours, give a second 2.5 mL dose

Do not give to babies less than 2 months of age • Do not give more than 2 doses

• Leave at least 4 hours between doses • If further doses are needed, talk to your doctor or pharmacist

Child's Age	How Much	How often (in 24 hours)
3- 6 months	One 2.5 mL spoonful	4 times
6 - 24 months	One 5 mL spoonful	4 times
2 - 4 years	One 5 mL spoonful and one 2.5 mL spoonful	4 times
4 - 8 years	Two 5 mL spoonfuls	4 times
8 - 10 years	Three 5 mL spoonfuls	4 times
10 - 12 years	Four 5 mL spoonfuls	4 times

• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.

Do not give this medicine with any other paracetamol-containing product.

If you give more Disprol Paediatric than you should

Immediate medical advice should be sought in the event of an overdose even if the child feels well, because of the risk of delayed, serious liver damage.

If you forget to give Disprol Paediatric

Do not take a double dose to make up for a forgotten dose. Just take the next dose when due.

If you have any further questions on the use of this product, ask your pharmacist or doctor.

4.    Possible side effects

Occasionally allergic reactions such as skin rashes may occur. Very rarely, patients can feel unusually tired, get unexpected bruising or bleeding and get more infections than usual.

Tell your doctor or pharmacist if you notice any side effects after taking this medicine.

5.    How to store

Keep out of the reach and sight of children. Store below 25°C. Protect from light. Do not freeze.

Do not use after the expiry date shown on the label and carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

Each 5ml of the suspension contains 120mg of the active ingredient paracetamol. The other ingredients are hydrogenated glucose syrup, glycerol, carbomer, sodium hydroxide, methyl hydroxybenzoate, propyl hydroxybenzoate, citric acid, saccharin sodium, banana flavour, riboflavine sodium phosphate and water. Disprol Paediatric is available in 100ml bottles with a measuring spoon.

Marketing Authorisation Holder and Manufacturer: Reckitt Benckiser Healthcare

(UK) Ltd, Hull HU8 7DS. Tel: 0500 455 456

PL 00063/0021

Leaflet last revised April 2013.